Market Newsdesk

• CEPI to fund Gritstone’s work on second-generation vaccines against SARS-CoV-2, the virus causing COVID-19, including a clinical trial in South Africa and manufacturing optimization
• Gritstone’s second-generation vaccines include self-amplifying mRNA (SAM) to deliver multiple antigens (spike protein plus additional sequence from non-spike genes)
  providing the potential for deep, broad, and durable immunity against SARS-CoV-2 variants
• Gritstone’s CORAL Phase 1 program – which includes the CEPI-funded trial – is establishing optimal dosing and antigenic content in young individuals, the elderly, the previously vaccinated, and the immunocompromised, including people living with HIV
  

EMERYVILLE, Calif., Aug. 17, 2021 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced that the company entered into a funding agreement of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of Gritstone’s CORAL COVID-19 vaccine program with an initial focus in South Africa.

“COVID-19 variants are already rendering some of our vaccines less effective, so it is critical that we don’t let our guard down: we must continue to invest in critical vaccine R&D if we are to stay one step ahead of this deadly virus,” said Richard Hatchett, M.D., CEO of CEPI. “CEPI is planning for the longer-term management of COVID-19 by investing in vaccines to address the threat of variants, and I’m pleased to work with Gritstone to advance the development of this innovative vaccine candidate which can be made globally accessible through COVAX if it is proven to be safe and effective.”

“Our unique approach combines our self-amplifying mRNA platform with a broad set of viral antigens beyond spike intended to drive robust and durable immune responses comprising both neutralizing antibodies and CD8+ T cells. With this unique antigenic breadth, our CORAL vaccine may offer protection against emerging spike variants of SARS-CoV-2 that appear challenging for first generation vaccines,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone. “We are honored to be supporting CEPI in their mission to help find new vaccine solutions to battle this deadly virus on a global scale and help prevent current and perhaps future COVID outbreaks.”

Professor Shabir Madhi, dean of the Faculty of Health Sciences and professor of vaccinology at the University of the Witwatersrand, Johannesburg, South Africa and a member of the WHO Strategic Advisory Group of Experts on Immunization (SAGE) commented, “The ongoing mutations in SARS-CoV-2 leading to increased transmissibility and relative immune evasion from most first generation COVID-19 vaccines that primarily target the spike protein, call for alternate approaches aimed at driving CD8+ immunity against spike and more conserved epitopes. This could assist in reducing both infectiousness of breakthrough cases and overall virus transmission.” Professor Mahdi will lead the Gritstone clinical trial in South Africa.

Under the terms of the agreement, CEPI will fund a multi-arm Phase 1 study evaluating the CORAL program’s SAM vaccine in naïve, convalescent, and HIV+ patients. The funding will also support pre-clinical studies, scale-up and formulation development to enable more stable drug product. The study will evaluate two different SAM vaccine constructs that each target both the spike protein and other SARS-CoV-2 targets and are designed to drive both robust B and T cell immune responses. The trial is expected to initiate before the end of 2021.

CEPI is committed to global equitable access to COVID-19 vaccines so, through this agreement, CEPI and Gritstone bio have agreed that this vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility aims to deliver equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.

About the CORAL Program

Gritstone’s CORAL program is a second-generation SARS-CoV-2 vaccine platform delivering spike and additional SARS-CoV-2 T cell epitopes, offering the potential for deep, broad, and durable protection against SARS-CoV-2 variants. Delivery vectors can comprise a chimpanzee adenovirus, self-amplifying mRNA or both. The program is supported by several key relationships: La Jolla Institute for Immunology, Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Disease (NIAID), and the Coalition for Epidemic Preparedness Innovations (CEPI). A Phase 1 clinical trial is currently being sponsored by NIAID examining the reactogenicity and immunogenicity of CORAL in healthy volunteers and as a booster for previously vaccinated volunteers. Gritstone is sponsoring and conducting its own Phase 1 studies in select populations, which are anticipated to begin before the end of 2021. Together with the CEPI supported study, this set of clinical trials will test four different vaccine candidates and establish optimal dosing and antigenic content for the CORAL program in young individuals, the elderly, the previously vaccinated, and the immunocompromised.

About Gritstone

Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary AI -based platform, Gritstone EDGE^TM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and, second, the ability to develop, manufacture, and deliver selected antigens to the patient’s immune system to drive the destruction of tumors or virally-infected cells. . The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off-the-shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine, with support from departments within the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and through a license agreement with La Jolla Institute for Immunology. Additionally, the company has a global collaboration for the development of a therapeutic HIV vaccine with Gilead Sciences. For more information, please visit gritstone.com.

Gritstone Forward-Looking
Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstone’s therapeutic programs; the advancements in the company’s ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Quarterly Report on Form 10-Q filed on August 5, 2021 and any current and periodic reports filed with the Securities and Exchange Commission.

Gritstone Contacts

Media:
Dan Budwick
1AB
(973) 271-6085
[email protected]

Investors:
Celia Economides
Chief Financial Officer
[email protected]

Acquisition Expands Recro’s Global Customer Base and Service Offerings, Creates Bi-Coastal CDMO, Diversifies Pipeline and Revenue Sources, and Provides Additional Pathway for Continued Growth

Webcast Scheduled for 11:00 a.m. Eastern on Thursday, August 19, 2021

EXTON, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Recro Pharma, Inc. (“Recro”; NASDAQ: REPH), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced that company management will host a webcast to discuss the company’s recently announced acquisition of IRISYS, a San Diego-based CDMO that possesses capabilities that complement and expand those of Recro. The webcast will be held at 11:00 a.m. Eastern on Thursday, August 19, 2021.

During the event, Recro’s management team will discuss the rationale for its acquisition of IRISYS and provide an overview of the transaction’s expected impact on the company’s ongoing growth strategy. The discussion will highlight Recro’s operations on both the East and West Coast of the U.S., as well as the organization’s expanded global client base and enhanced capabilities now spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of dosage forms.

To access the webcast, please do so by visiting the “Events” page in the Investor section of the Company’s website, www.recrocdmo.com. In addition, an archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

About Recro

Recro (NASDAQ: REPH) is a contract development and manufacturing organization (CDMO) with capabilities from early feasibility to commercial manufacturing. With an expertise in solving complex manufacturing problems, Recro is a CDMO providing oral solid dosage form development, end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market.

In addition to our experience in handling DEA controlled substances and developing and manufacturing modified release oral solid dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 120,000 square feet, in Gainesville, Georgia.

For more information about Recro’s CDMO solutions, visit recrocdmo.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, the Company’s expectations regarding, the potential benefits of the acquisition of IRISYS, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Factors that could cause the Company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks that the results and potential of the combined business and the combination IRISYS’ business with the Company’s business may not be as anticipated; the potential impact of the IRISYS acquisition to the Company’s growth strategy; the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the Company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the Company’s manufacturing services; the average profitability, or mix, of the products the Company manufactures; the Company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the Company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

BOCA RATON, Fla., Aug. 17, 2021 (GLOBE NEWSWIRE) — Greenlane Holdings, Inc. (“Greenlane” or “the Company”) (Nasdaq: GNLN), a global house of brands and one of the largest sellers of premium cannabis accessories, child-resistant packaging, and specialty vaporization products, today reported financial results for the second quarter ended June 30, 2021 (“Q2 2021”).

Q2 2021 Highlights

• Total revenue increased 7.1% to $34.7 million for Q2 2021, compared to $32.4 million for Q2 2020;
  • Q2 2021 core revenue (defined as non-nicotine revenue) grew 14.9% to $34.5 million, compared to $30.0 million in Q2 2020;
• Achieved third consecutive quarterly sales record for Greenlane Brands, which grew to $9.0 million in Q2 2021, up 62.5% compared to $5.5 million in sales for Q2 2020;
  • Greenlane Brands accounted for 25.9% of Q2 2021 total revenue compared with 17.1% of total revenue for Q2 2020;
• Successfully transitioned to core business lines. Core revenue accounted for 99.3% of total revenue for Q2 2021;
• Gross profit and gross margin grew by $1.0 million and 1.3%, respectively, to $7.8 million and 22.4%, compared to $6.8 million and 21.0% in Q2 2020;
• Subsequent to quarter end, the Company completed a $32.0 million registered direct offering priced at-the-market.

Management Commentary

“Our second quarter 2021 results reflect the success of our efforts to drive growth in our core business lines and higher margin Greenlane brands,” said Aaron LoCascio, Greenlane’s Chairman and Chief Executive Officer. “I am proud of our accomplishments and want to thank our entire team for their ongoing dedication as we execute on the opportunity ahead. During the quarter, we drove solid Greenlane Brands revenue growth, up 62% year over year and representing 26% of our total Q2 revenue, supported by strong organic growth.”

Mr. LoCascio added, “Our focus on growing our portfolio of owned brands and driving strong performance from our existing brand portfolio, combined with our pending merger with KushCo, has positioned our business to be the leader in the ancillary cannabis space and to build strong, long-term value for both our customers, partners, employees, and shareholders.”

Financial Summary

Net sales were $34.7 million in Q2 2021, compared to $32.4 million in Q2 2020, an increase of $2.3 million, or 7.1%. As the Company continues to focus on core (non-nicotine) sales and higher-margin products, including Greenlane Brands, Q2 2021 net sales included negligible nicotine revenue compared to the prior year period.

Gross profit was $7.8 million, or 22.4% of net sales in Q2 2021, compared to $6.8 million, or 21.0% of net sales in Q2 2020. While merchandise margin increased by 2.3% and resulted in a $0.8 million or 7.4% increase in merchandise gross profit, the improvements were slightly offset by a $0.9 million increase in inventory adjustments and a $0.5 million increase in customs duties and fees.

Cash totaled $11.6 million as of June 30, 2021. As of June 30, 2021, working capital was $36.4 million, compared to working capital of $54.2 million, as of December 31, 2020.

Net sales for our United States reporting segment increased $4.3 million, or 16.4%, to $30.7 million in Q2 2021, compared to approximately $26.4 million in the same period in 2020. Net Sales for our Canadian reporting segment decreased to approximately $1.4 million for Q2 2021 compared to approximately $3.5 million in the same period in 2020, primarily due to a decrease of $1.1 million in non-core revenue sales as a result of the Company’s strategic shift away from low-margin nicotine sales. Net sales for our European reporting segment remained flat at $2.6 million for Q2 2021, primarily due to the third-party website sales, which resulted in $0.4 million of additional net sales and a $0.2 million growth in B2B net sales, which offset a $0.6 million decrease in E-Commerce sales.

Conference Call Information

Greenlane will host a conference call Tuesday, August 17^th, 2021, to discuss these results. Aaron LoCascio, Chief Executive Officer, will host the call starting at 8:30 a.m. Eastern Time.

About Greenlane Holdings, Inc.

Greenlane Holdings, Inc. (NASDAQ: GNLN) is a global house of brands and one of the largest sellers of premium cannabis accessories, child-resistant packaging, and specialty vaporization products to smoke shops, dispensaries, and specialty retail stores, as well as direct to consumer through its online e-commerce platforms, Vapor.com, Higherstandards.com, Aerospaced.com, Harringglass.com, Eycemolds.com, Canada.Vapor.com, Azarius.net, Vaposhop.com, and recently-acquired Puffitup.com. Founded in 2005, Greenlane serves more than 7,000 retail locations and has over 250 employees with operations in United States, Canada, and Europe. With a strong global footprint, Greenlane has been the partner of choice for many of the industry’s leading brands, who chose to leverage its strong distribution platform, unparalleled customer service, and highly efficient operations and logistics to accelerate their growth. Greenlane’s curated portfolio of owned brands includes EYCE, packaging innovator Pollen Gear™, VIBES™ rolling papers, Marley Natural™ Accessories; K.Haring Glass Collection, Aerospaced grinders, and Higher Standards which offers both an upscale product line as well as an innovative retail experiences with flagship stores located in Chelsea Market, New York and Malibu, California.

For additional information, please visit: https://gnln.com/.

Use of Non-GAAP Financial Measures

Greenlane discloses Adjusted Net Loss and Adjusted EBITDA, which are non-GAAP performance measures, because management believes these metrics assist investors and analysts in assessing our overall operating performance and evaluating how well we are executing our business strategies. You should not consider Adjusted Net Loss or Adjusted EBITDA as alternatives to net loss, as determined in accordance with U.S. GAAP, as indicators of our operating performance. Adjusted Net Loss and Adjusted EBITDA have limitations as an analytical tool. Some of these limitations are:

• Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future and adjusted EBITDA does not reflect capital expenditure requirements for such replacements or for new capital expenditures;
• Adjusted EBITDA does not include interest expense, which has been a necessary element of our costs, and income tax payments we may be required to make;
• Adjusted EBITDA and Adjusted Net Loss do not reflect equity-based compensation;
• Adjusted EBITDA and Adjusted Net Loss do not reflect transaction and other costs which are generally incremental costs that result from contemplated or completed transaction;
• Adjusted EBITDA and Adjusted Net Loss do not reflect other one-time expenses and income, including consulting costs related to the implementation of our ERP system and the reversal of an allowance against indemnification receivables associated with the EU VAT liability;
• Other companies, including companies in our industry, may calculate adjusted EBITDA differently, which reduces its usefulness as a comparative measure.

Because Adjusted Net Loss and Adjusted EBITDA do not account for these items, these measures have material limitations as indicators of operating performance. Accordingly, management does not view Adjusted Net Loss or Adjusted EBITDA in isolation or as substitutes for measures calculated in accordance with U.S. GAAP.

For more information on Greenlane’s non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial measures, please see the “Reconciliation of GAAP to Non-GAAP Financial Measures” table in this press release.

Forward Looking Statements

Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statements. These forward-looking statements include, among others: comments relating to the current and future performance of the Company’s business; the pending merger with KushCo; the Company’s strategies; the impacts of acquisitions and other similar transactions; growth in demand for the Company’s products; growth in the market for cannabis and nicotine; the Company’s marketing and commercialization efforts; and the Company’s financial outlook and expectations. For a description of factors that may cause the Company’s actual results or performance to differ from its forward-looking statements, please review the information under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2020, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021 and the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Additional information is also set forth in Greenlane’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to Greenlane on the date hereof. Greenlane undertakes no duty to update this information unless required by law.

Media Contact
MATTIO Communications
[email protected]

Investor Contact

Rob Kelly
Investor Relations, MATTIO Communications
[email protected]
1-416-992-4539

GREENLANE HOLDINGS, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES

(Unaudited)

The reconciliation of our Net Loss to Adjusted Net Loss for each of the periods indicated is as follows:

The reconciliation of our Net Loss to Adjusted EBITDA for each of the periods indicated is as follows:

SUZHOU, China and PALO ALTO, Calif., Aug. 17, 2021 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported its unaudited financial results for the second quarter of the year and recent business highlights. Gracell will host a conference call today, Tuesday, August 17, at 8:00 am Eastern Time.

“We are very pleased with the significant progress we have made in 2021 across our key clinical, manufacturing and corporate objectives,” commented Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “Our innovative portfolio of autologous and allogeneic CAR-T cell therapies, built upon our rich cell therapy and gene editing expertise and proprietary FasTCAR and TruUCAR technology platforms, continues to meet key milestones and demonstrate encouraging and competitive therapeutic potential across multiple difficult to treat hematologic malignancies and solid tumors.”  

“Longer-term follow-up data for GC012F, our BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma designed on the next-day manufacturing FasTCAR platform, was presented at the ASCO 2021 Annual Meeting and the EHA 2021 Congress in June. We continue to see fast, deep and durable responses in a difficult to treat, predominantly high-risk patient population. Updates on longer-term follow-up for our study in T-ALL for GC027, our lead TruUCAR candidate, an off-the-shelf, stand-alone allogeneic CAR-T cell therapy, was presented at the AACR 2021 Annual Meeting this April. Data continues to be encouraging and we are planning on enrolling additional patients to expand the indication to AML. In March, we announced enrollment of the first patient in our pivotal Phase 1/2 clinical study of GC007g in China, an allogeneic donor-derived anti-CD19 CAR-T cell therapy for the treatment of r/r B-ALL and we are pleased to announce completion of the first dosing cohort for GC007g.”

Dr. Cao continued, “We are very happy to announce the timely expansion of our US team. In spring, we appointed Dr. Jenny (Yajin) Ni as Chief Technology Officer. Seasoned in CAR-T cell therapy CMC development and having successfully lead process development at both Pfizer and Allogene Therapeutics, Dr. Ni’s focus is supporting a smooth technology transfer to Lonza for our FasTCAR-enabled product candidate GC012F. In addition, we are excited about Dr. Grace Jiang joining Gracell as our Head of U.S. Regulatory Affairs reporting to our Chief Medical Officer Dr. Sersch. Dr. Jiang brings nearly 20 years of experience in biotechnology companies, including at Amgen, in regulatory affairs with filing experience in Multiple Myeloma. Dr. Ni and Dr. Jiang will be instrumental as we continue to advance our product development, and these key appointments also mark an important step to advance our presence in the U.S.”

“As we enter the second half of 2021, we will continue to build on our solid progress achieved so far. In the coming months of this year, we are planning on advancing exciting early pipeline candidates into clinical studies in China. We will enhance our R&D capabilities in the U.S., with our ongoing manufacturing collaboration with Lonza supporting a U.S. IND submission for the FasTCAR candidate GC012F in the first half of 2022. We also plan to expand our manufacturing capacity by developing a second facility in Suzhou, China in addition to our state-of-the-art, 66,000 sq. ft. GMP manufacturing facility, designed for fully-closed production capabilities to reduce contamination risks and optimize cost-efficiency. These clinical and operational developments will bring Gracell closer to delivering accessible and highly efficacious treatments for patients across a wider range of malignancies,” Dr. Cao concluded.

Second Quarter 2021 and Subsequent Highlights

GC012F for the treatment of multiple myeloma (MM):


GC012F is a FasTCAR-enabled dual-targeting BCMA/CD19 autologous
chimeric antigen receptor (
CAR)-T cell therapy that is currently being studied in an ongoing Phase 1 investigator-initiated trial (IIT) in China for the treatment of MM patients who are relapsed from or refractory to (r/r) prior therapies.

• Interim data presented at ASCO & EHA. Interim data presented at the ASCO 2021 Annual Meeting and the EHA 2021 Congress (Press Release May 2021). As of January 12, 2021, the study had enrolled and treated 19 patients at three dose levels with the highest dose level of 3×10⁵ cells/kg. Since the last update (reported at ASH 2020), additional patients were treated at the highest dose level.
• High risk patient population. Notably, 18 of the 19 patients (94.7%) treated were classified as high-risk according to mSMART 3.0 guidelines and patients had received a median of 5 prior lines of therapy. 94.7% (18/19) of the patients were triple exposed to a PI, IMiD, and at least a third treatment modality, including anti-CD38 targeted therapy.
• 100% MRD- sCR at dose level 3. Early Overall Response Rate (ORR) shows a promising 94.7% (18/19) with all responses being VGPR or better (sCR), highlighting fast, deep and durable responses in all dose levels. 100% of the patients treated at the highest dose level (n=9) obtained MRD- sCR.
• Favorable safety profile. The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome (CRS) (84% Grade 1/2, 11% (n=2) patients Grade 3). No Grade 4 or 5 CRS and no ICANS (immune effector cell-associated neurotoxicity) were observed in any of the 19 patients. Treatment-emergent adverse events (TEAEs) presented predominantly as cytopenias and AST increase. All TEAEs resolved with standard therapy. Patients are continued to be followed for efficacy and safety.
• IND in 1H2022. IND application submission in both the US and China planned within the first half of 2022.

GC007g for the treatment of B-cell acute lymphoblastic leukemia (B-ALL):


GC007g is a donor-derived CD19-targeted allogeneic CAR-T cell therapy for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy. The allogeneic approach, utilizing T-cells from a human leukocyte antigen (HLA)-matched healthy donor, has the potential to provide a novel treatment approach to patients not eligible for standard of care.

• First patient enrolled. Enrolled first patient in the pivotal seamless Phase 1/2 clinical trial to evaluate the safety and efficacy of GC007g in r/r B-ALL patients. (Press Release March 2021).
• First dosing cohort completed. Successful enrollment of first dosing cohort in the phase 1/2 seamless design study was completed.

GC027 for the treatment of adult relapsed/refractory T cell acute lymphoblastic leukemia (r/r T-ALL):
 GC027 is a TruUCAR-enabled CD7-targeted allogeneic CAR-T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult r/r T-ALL. GC027 is manufactured from T cells of non-HLA-matched healthy donors.

• Longer-term follow-up data presented AACR. Updated long-term follow-up data (data cut-off as of February 4, 2021) for GC027 was presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting (Press Release April 2021). Patients had received a median of six prior lines of therapy and received a single infusion of TruUCAR GC027 in one of three dose levels with the highest dose level at 1.5×10⁷ cells/kg. 
• Longest ongoing DOR 16.8 months. Six patients (100%) treated achieved a complete remission with or without complete blood count recovery (CR/CRi) and five of the six patients (83%) achieved MRD- CR. At 6 months post treatment, three out of five patients (60%) had maintained MRD- CR. After 18.5 months of follow up for the initial patients treated, one patient continued to be MRD- CR at 16.8 months. One patient maintained MRD- CR until 9 months and one patient with primary refractory disease (no response to VDP regimen) maintained his MRD- CR status until month 7. One additional patient treated presented initially with a high tumor burden and extensive extramedullary (EM) disease. After treatment with GC027 and as confirmed by PET CT scan, all EM lesions resolved. The patient achieved MRD- CR at day 28.
• No ICANS or aGvHD. All six patients tolerated a single infusion of TruUCAR GC027. No neurotoxicity events (ICANS) or acute graft-versus-host disease (aGvHD) were observed. CRS occurred in all patients and was managed with standard of care including tocilizumab. Overall safety findings were consistent with previous observations.
• IND in 2022. IND application submission in both the US and China planned in 2022.

Corporate Highlights:

• Expanded executive leadership. Expanded executive leadership team with the appointment of Dr. Jenny (Yajin) Ni, as Chief Technology Officer. Dr. Ni will strategically lead CAR-T process development, CMC and supply chain management activities at Gracell (Press Release May 2021)
• Exclusive License Agreement with FutureGen Biopharmaceutical Co., Ltd. On May 11, 2021, we entered into an exclusive license agreement with FutureGen Biopharmaceutical Co., Ltd. (“FutureGen”) under which FutureGen grants to Gracell an exclusive, worldwide, sublicensable license under FutureGen’s patent rights to research, develop, manufacture, commercialize, and otherwise exploit the patent rights in the field of engineered or modified immune cell therapies for solid tumors. (Press Release August 2021)

Financial Results for the Second Quarter Ended June 30, 2021

Research and development expenses for the three months ended June 30, 2021 were RMB65.3 million (US$10.1 million), as compared to RMB40.8 million in the corresponding prior year period. This increase was primarily driven by increases of RMB8.2 million (US$1.3 million) in labor costs due to the further expansion in business as well as an increases of RMB6.9 million (US$1.1 million) and RMB5.1 million (US$0.8 million) in depreciation expenses of research and development facilities and in costs incurred to advance preclinical and clinical pipeline, an increase of RMB2.8 million (US$0.4 million) in professional service expenses and an increase of RMB1.8 million (US$0.3 million) in recognition of share-based compensation expenses upon the completion of initial public offering, respectively.

Administrative expenses for the three months ended June 30, 2021 were RMB30.4 million (US$4.7 million), compared to RMB7.0 million for the corresponding prior year period. This increase was primarily related to an increase of RMB7.7 million (US$1.2 million) in recognition of share-based compensation expenses upon the completion of initial public offering, an increase of RMB6.3 million (US$1.0 million) attributable to labor costs due to expansion of administrative functions, an increase of RMB5.2 million (US$0.8 million) in financial and legal consulting fee, an increase of RMB2.3 million (US$0.4 million) of insurance expense for the employees and also an increase of RMB0.7 million (US$0.1 million) in lease-related expense.

Interest income for the second quarter of 2021 was RMB1.7 million (US$0.3 million) as compared to RMB1.0 million for the corresponding prior year period.

Foreign exchange loss for the three months ended June 30, 2021 was RMB0.8 million (US$0.1 million), compared to a foreign exchange loss of RMB0.1 million for the corresponding prior year period. This increase in the foreign exchange loss of RMB0.7 million was primarily attributable to unfavorable foreign exchange rate fluctuating during the quarter ended June 31, 2021.

Net loss attributable to ordinary shareholders for the three months ended June 30, 2021 was RMB96.2 million (US$14.9 million), compared to RMB63.1 million for the corresponding prior year period.

Balance Sheet Highlights

As of June 30, 2021, we had RMB2,053.6 million (US$318.1 million) in cash and cash equivalents and short-term investments. During the first half of the year, we completed an initial public offering of 11,000,000 American Depositary Shares (“ADSs”), each representing five ordinary shares, at a public offering price of $19.00 per ADS. In connection with the initial public offering, we granted the underwriters an option to purchase up to an additional 1,650,000 ADSs at the initial public offering price, which was exercised in full by the underwriters. The net proceeds from these transactions were approximately US$220 million.

We early adopted ASU 2016-02, Lease (Topic 842), in the first quarter of 2021. As of June 30, 2021, we had operating lease liabilities of RMB39.5 million (US$6.1 million) and operating lease right-of-use assets of RMB39.2 million (US$6.1 million).

In the first quarter of 2021, we received a payment from the depositary bank of RMB14.5 million (US$2.2 million) mostly to reimburse the expenses related to the establishment of ADS facility. The payment is initially recognized as a liability and is being amortized over the facility arrangement period. As of June 30, 2021, we had the related other current liabilities of RMB2.9 million (US$0.44 million) and other non-current liabilities of RMB10.1 million (US$1.6 million).

In addition, as of June 30, 2021, we had short-term borrowings and current portion of long-term borrowings of RMB58.1 million (US$9.0 million) and long-term borrowings of RMB55.6 million (US$8.6 million).

As of June 30, 2021, 336,217,511 ordinary shares, par value of US$0.0001 per share, were issued and outstanding. As of June 30, 2021, 11,707,435 options were granted and 10,946,710 options were outstanding, and 303,030 restricted share units (“RSUs”) were granted under our employee stock option plan. Each of our ADS represents five ordinary shares.

Conference Call Details

Tuesday, August 17, 2021 at 8:00 am ET
Investor domestic dial-in: 877-407-0784
Investor international dial-in: +1 201-689-8560
Conference ID: 13722146
Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

The webcast replay will be available on the Gracell website at ir.gracellbio.com for 90 days following the completion of the call.

Exchange Rate Information

This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.4566 to US$1.00, the rate in effect as of June 30, 2021 published by the Federal Reserve Board.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered “off-the-shelf” at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft vs host disease (GvHD) without the need of being co-administered with additional immunosuppressive drugs.

About Gracell

Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

Follow @GracellBio on LinkedIn

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words “anticipate,” “look forward to,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled “Risk Factors” in Gracell’s most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Media contact

Marvin Tang

[email protected]
 

Investor contact

Gracie Tong

[email protected]